ACELL Mesh for Paraesophageal Hernia Repair

Completed

• Conditions: Paraesophageal Hernia
• Interventions: Device: Control; Device: Matristem

• Registration Number: NCT03058731
• Lead Sponsor: University of South Florida

Brief Summary

This is a prospective, case-matched, systematic follow up of up to 70 pre-existing patients whom underwent paraesophageal hernia repair between June 1, 2012 and September 30, 2016. Patients whom are willing to participate in the study will be asked to return for a one time follow up visit to reassess for hiatal hernia recurrence both symptomatically and radiologically to compare the efficacy of the use of MatriStem Surgical Matrix (ACell) mesh to other biologic meshes.

Detailed Description

The participating "MatriStem" patients (N=35) will be matched to "control" patients who were treated surgically by Dr. Vic Velanovich or Dr. Michael Albrink for paraesophageal hernia with a biological mesh other than MatriStem Surgical Matrix (N=35) during the study timeframe at Tampa General Hospital. Patients will be matched by age (+ 5 years), gender, and operative approach (laparoscopic, laparotomy, or thoracic approach).

Study participation will require only one visit. Once the patient signs the consent form, operative details and the postoperative course will be reviewed retrospectively.

Visit 1 (≥ 12 months post-PEHR)

1. Review the study with the subject and/or subject's legal representative, and obtain written informed consent and HIPAA authorization.

2. Assign the subject a unique screening/enrollment number (assigned sequentially starting from 001).

3. Pregnancy test if subject is of childbearing potential

4. Confirm subject eligibility.

5. Record demographics data, which includes date of birth, race, ethnicity, and gender.

6. Record current clinical symptoms in relation to the HH.

7. Record medications, including over-the-counter and herbal medications, taken postoperatively in relation to the HH.

8. Record medical history with respect to the paraesophageal hernia prior to the surgical repair. If available, the following information will be recorded: hernia type, hernia size, organo-axial, or meso-axial rotation, and operative approach (laparoscopic, laparotomy, or thoracic approach).

9. Record medical history with respect to the paraesophageal hernia after the surgical repair (size of mesh implant, length of surgery \[calculated as the time from incision to wound closure\], postoperative complications to include need for reoperation, mesh migration, reherniation, etc \[from date of hospital discharge to study visit\], and symptom frequency).

10. Perform esophagogram at TGH.

11. Administer GERD-HRQL symptom severity questionnaire.

12. Administer SF-36 generic quality of life instrument.

Study Timeline

• Study Start: 2016-02-02
• Study First Submitted: 2017-02-16
• Study First Submitted QC: 2017-02-16
• Study First Posted: 2017-02-23
• Primary Completion: 2018-04-01
• Study Completion: 2019-01-28
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-26
• Last Update Posted: 2019-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• Age 18 years and older
• Underwent primary or re-do PEHR with biological mesh by Dr. Vic Velanovich or Dr. Michael Albrink between June 1, 2012 and September 30, 2016
• Written informed consent obtained from subject prior to esophagogram procedure and ability for subject to comply with the requirements of the study

Exclusion Criteria

• Age < 18 years of age
• Underwent PEHR by a surgeon other than Dr. Vic Velanovich or Dr. Michael Albrink
• Underwent PEHR outside of the timeframe of June 1, 2012 and September 30, 2016
• Subject is involved in ongoing medical litigation, confirmed via subject report
• Subject is incarcerated, confirmed via subject report
• Pregnant

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Control	Other biological mesh
Matristem	Matristem	Hernia repair with MatriStem Surgical Matrix

Primary Outcome Measures

Name	Time	Method
Rate of hernia recurrence	12 months

Secondary Outcome Measures

Name	Time	Method
Mean vertical height of hiatal hernia	12 months	For patients with hiatal hernia recurrence
Rate of postoperative complications	12 months
Mean GERD-Health Related QOL score	12 months
Mean cross-sectional area of hiatal hernia	12 months	For patients with hiatal hernia recurrence
Mean SF-36 QOL score	12 months

Trial Locations

Locations (1)

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States